This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs).

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> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion.

The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.

Time to First Cannulation [ Time Frame: Time of access placement to first cannulation, assessed up to one week ] [ Designated as safety issue: No ]

The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.

Time to Potential Central Venous Catheter Removal [ Time Frame: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123 ] [ Designated as safety issue: No ]

The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.

The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.

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The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin.

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The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.

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The patient is enrolled in another investigational study.

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The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.

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Study device is intended to be used temporarily.

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The patient has had >2 previous arteriovenous accesses in treatment arm.

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Patient is taking Aggrenox®.

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The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.

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The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(>10 mg), cyclosporine, tacrolimus or cyclophosphamide.

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The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.

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Life expectancy is less than 12 months.

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The patient is pregnant.

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The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173718